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Clinical Trials/NCT05558813
NCT05558813
Withdrawn
Not Applicable

Prospective Cardiac Magnetic Resonance Imaging Study in Duchenne Muscular Dystrophy (DMD-CMP)

Assistance Publique - Hôpitaux de Paris1 site in 1 country150 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Cardiac MRI
Conditions
Duchenne Muscular Dystrophy
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
150
Locations
1
Primary Endpoint
Late gadolinium enhancement burden on cardiac MRI
Status
Withdrawn
Last Updated
5 months ago

Overview

Brief Summary

The purpose of this study is to describe the progression of tissular and functional myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays.

Detailed Description

This study is to describe the progression of tissular (late gadolinium enhancement, T1, T2, ECV assessments) and functional (segmental and global contractility, strain) myocardial abnormalities in patients with Duchenne muscular dystrophy using cardiac magnetic resonance imaging and blood biomarkers assays (troponin I, NTproBNP). Comparison between baseline and 2-years assessments will be conducted.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
April 1, 2029
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

DMD-CMP cohort

Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy

Intervention: Cardiac MRI

DMD-CMP cohort

Minor (≥ 6 years) and major patients with genetically proven Duchenne myopathy

Intervention: Blood assays

Outcomes

Primary Outcomes

Late gadolinium enhancement burden on cardiac MRI

Time Frame: 2 years

Secondary Outcomes

  • Left ventricular ejection fraction on cardiac MRI(2 years)
  • Left ventricular systolic circumferentiel strain ejection fraction on cardiac MRI(2 years)
  • Global T1 on cardiac MRI(2 years)
  • Left ventricular systolic longitudinal strain on cardiac MRI(2 years)
  • Global T2 on cardiac MRI(2 years)
  • Global extracellular volume on cardiac MRI(2 years)
  • NTproBNP assay in the blood(2 years)
  • Troponin I assay in the blood(2 years)
  • Left ventricular systolic radial strain ejection fraction on cardiac MRI(2 years)

Study Sites (1)

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